Mechanisms of Open and Hidden Placebo in Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Electroencephalography (EEG): Frontal alpha asymmetry
研究概览
简要总结
This trial aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects thus providing a novel mechanism to explain placebo effects that can be used to ultimately enhance stroke rehabilitation therapies.
详细描述
Placebo effect leads to significant effects on brain excitability and connectivity, ultimately influencing clinical outcomes, including motor learning in stroke. This trial will provide critical mechanistic data to improve the understanding of placebo in stroke clinical trials, as to solve methodological and ethical dilemma in research designs, and to improve its clinical outcomes. It aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects. For this purpose, the investigators plan to recruit 56 chronic stroke participants, that will be randomized using blocked randomization in a 2:2:2:1 proportion to one of the following groups, respectively: 1) open placebo (OP) alone (16 subjects); 2) sham rTMS alone (16 subjects); 3) no intervention (16 subjects); or 4) active rTMS alone (8 subjects). All four groups will undergo 2 weeks of daily intervention visits (10 sessions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with hemiparesis due to chronic stroke
- •Stroke duration of 6 months or more
- •Fugl-Meyer scale upper extremity motor assessment score of > 11 and ≤ 56
- •Pre-stroke disability (defined as a score of < 3 on the Modified Rankin Scale)
- •Age 18 or older
排除标准
- •Stroke of anterior cerebral artery territory with prefrontal lesion and stroke-related decreased EEG power in the prefrontal cortex
- •Unable to understand instructions
- •TMS contraindications: electronic hardware in close contact to the discharging coil such as cochlear implant, internal pulse generator or medical pump
- •Concurrent unstable medical conditions
- •A score of 24 or higher on the Hamilton Depression Rating Scale (HDRS)
- •Joint or paretic extremity pain likely to interfere with assessments
研究组 & 干预措施
Active rTMS
The participant will receive a session of low frequency rTMS to the contralesional primary motor cortex. Low frequency rTMS stimulation will be applied according to the following parameter: intensity of 80% MT (intensity could be adjusted if not comfortable to the subject), frequency of 1 Hz, 1200 pulses as a single, continuous train lasting 20 minutes.
干预措施: Active rTMS (Device)
Sham rTMS
The investigators will place the coil in the same location, usually used for the active stimulation with the same stimulation parameters. However, the investigators will replace the active coil with a sham coil to ensure no stimulation is provided.
干预措施: Sham rTMS (Device)
Open Placebo
The open placebo will consist of typical prescription medicine bottle of placebo pills with a label clearly marked "placebo pills" "take 2 pills twice daily." The placebo pills are made from Microcrystalline Cellulose.
干预措施: Open Placebo (Dietary Supplement)
No Intervention
It consists of treatment-as-usual group.
结局指标
主要结局
Electroencephalography (EEG): Frontal alpha asymmetry
时间窗: Change from 2 weeks to baseline
The FAA score will be calculated by subtracting the natural log-transformed alpha power in the left frontal region (F3, F7, Fp1) from the natural log-transformed power in the right frontal region (F4, F8, Fp2).
次要结局
- Premotor-M1 (PM-M1) connectivity(Change from 2 weeks to baseline)
- Fugl-Meyer motor scale (FM)(Change from 2 weeks to baseline)
研究者
Felipe Fregni, MD, PhD, MPH
Director of Spaulding Neuromodulation Center
Spaulding Rehabilitation Hospital